Atezolizumab

Class
Targeted therapy
Subclass
Anti-PD-L1 monoclonal antibodies
Substance name
Atezolizumab
Brand names
Tecentriq®
Common formulations
Solution for injection
Dosage and administration
Adults patients
Alveolar soft part sarcoma • Unresectable or metastatic, monotherapy
•
840 mg IV q2 weeks until disease progression or unacceptable toxicity
Administer the first infusion over 60 minutes; if tolerated, administer subsequent infusions over 30 minutes.
Alternative
•
1,200 mg IV q3 weeks until disease progression or unacceptable toxicity
Administer the first infusion over 60 minutes; if tolerated, administer subsequent infusions over 30 minutes.
Alternative
•
1,680 mg IV q4 weeks until disease progression or unacceptable toxicity
Administer the first infusion over 60 minutes; if tolerated, administer subsequent infusions over 30 minutes.
HCC • Unresectable or metastatic, no prior systemic therapy
•
840 mg IV q2 weeks until disease progression or unacceptable toxicity
Administered in combination with bevacizumab intravenously 15 mg/kg q3 weeks, with atezolizumab given before bevacizumab when administered on the same day. Administer the first infusion over 60 minutes; then, if well-tolerated, subsequent infusions should be given over 30 minutes.
Alternative
•
1,200 mg IV q3 weeks until disease progression or unacceptable toxicity
Administered in combination with bevacizumab intravenously 15 mg/kg q3 weeks, with atezolizumab given before bevacizumab when administered on the same day. Administer the first infusion over 60 minutes; then, if well-tolerated, subsequent infusions should be given over 30 minutes.
Alternative
•
1,680 mg IV q4 weeks until disease progression or unacceptable toxicity
Administered in combination with bevacizumab intravenously 15 mg/kg q3 weeks, with atezolizumab given before bevacizumab when administered on the same day. Administer the first infusion over 60 minutes; then, if well-tolerated, subsequent infusions should be given over 30 minutes.
Melanoma in patients with BRAF V600 mutation • Unresectable or metastatic
•
840 mg IV q2 weeks until disease progression or unacceptable toxicity
Administered in combination with cobimetinib 60 mg orally daily (21 days on and 7 days off) and vemurafenib 720 mg orally BID. Before initiating atezolizumab, complete a 28-day treatment cycle of cobimetinib 60 mg orally once daily (21 days on and 7 days off) and vemurafenib 960 mg orally twice daily from days 1-21 and vemurafenib 720 mg orally twice daily from days 22-28. Administer the first infusion over 60 minutes; if tolerated, administer subsequent infusions over 30 minutes.
Alternative
•
1,200 mg IV q3 weeks until disease progression or unacceptable toxicity
Administered in combination with cobimetinib 60 mg orally daily (21 days on and 7 days off) and vemurafenib 720 mg orally BID. Before initiating atezolizumab, complete a 28-day treatment cycle of cobimetinib 60 mg orally once daily (21 days on and 7 days off) and vemurafenib 960 mg orally twice daily from days 1-21 and vemurafenib 720 mg orally twice daily from days 22-28. Administer the first infusion over 60 minutes; if tolerated, administer subsequent infusions over 30 minutes.
Alternative
•
1,680 mg IV q4 weeks until disease progression or unacceptable toxicity
Administered in combination with cobimetinib 60 mg orally daily (21 days on and 7 days off) and vemurafenib 720 mg orally BID. Before initiating atezolizumab, complete a 28-day treatment cycle of cobimetinib 60 mg orally once daily (21 days on and 7 days off) and vemurafenib 960 mg orally twice daily from days 1-21 and vemurafenib 720 mg orally twice daily from days 22-28. Administer the first infusion over 60 minutes; if tolerated, administer subsequent infusions over 30 minutes.
Non-small cell lung cancer • Stage II-IIIA, PD-L1 expression ≥ 1%, adjuvant setting, monotherapy, following resection and platinum-based chemotherapy
•
840 mg IV q2 weeks for up to 1 year or until disease progression or unacceptable toxicity
Administer the first infusion over 60 minutes; if tolerated, administer subsequent infusions over 30 minutes.
Alternative
•
1,200 mg IV q3 weeks for up to 1 year or until disease progression or unacceptable toxicity
Administer the first infusion over 60 minutes; if tolerated, administer subsequent infusions over 30 minutes.
Alternative
•
1,680 mg IV q4 weeks for up to 1 year or until disease progression or unacceptable toxicity
Administer the first infusion over 60 minutes; if tolerated, administer subsequent infusions over 30 minutes.
Non-small cell lung cancer • Metastatic, progressed during or after platinum-based chemotherapy, monotherapy
•
840 mg IV q2 weeks until disease progression or unacceptable toxicity
Administer the first infusion over 60 minutes; if tolerated, administer subsequent infusions over 30 minutes.
Alternative
•
1,200 mg IV q3 weeks until disease progression or unacceptable toxicity
Administer the first infusion over 60 minutes; if tolerated, administer subsequent infusions over 30 minutes.
Alternative
•
1,680 mg IV q4 weeks until disease progression or unacceptable toxicity
Administer the first infusion over 60 minutes; if tolerated, administer subsequent infusions over 30 minutes.
Non-small cell lung cancer without EGFR mutations or ALK genomic aberrations • Metastatic, PD-L1 expression ≥ 50% or PD-L1 stained tumor-infiltrating immune cells ≥ 10%, first-line setting, monotherapy
•
840 mg IV q2 weeks until disease progression or unacceptable toxicity
Administer the first infusion over 60 minutes; if tolerated, administer subsequent infusions over 30 minutes.
Alternative
•
1,200 mg IV q3 weeks until disease progression or unacceptable toxicity
Administer the first infusion over 60 minutes; if tolerated, administer subsequent infusions over 30 minutes.
Alternative
•
1,680 mg IV q4 weeks until disease progression or unacceptable toxicity
Administer the first infusion over 60 minutes; if tolerated, administer subsequent infusions over 30 minutes.
Non-small cell lung cancer without EGFR mutations or ALK genomic aberrations • Non-squamous, metastatic, first-line setting
•
840 mg IV q2 weeks until disease progression or unacceptable toxicity
Administered in combination with bevacizumab, paclitaxel, and carboplatin or paclitaxel protein-bound and carboplatin, with atezolizumab given before chemotherapy when administered on the same day. Administer the first infusion over 60 minutes; if tolerated, administer subsequent infusions over 30 minutes.
Alternative
•
1,680 mg IV q4 weeks until disease progression or unacceptable toxicity
Administered in combination with bevacizumab, paclitaxel, and carboplatin or paclitaxel protein-bound and carboplatin, with atezolizumab given before chemotherapy when administered on the same day. Administer the first infusion over 60 minutes; if tolerated, administer subsequent infusions over 30 minutes.
Alternative
•
1,200 mg IV q3 weeks until disease progression or unacceptable toxicity
Administered in combination with bevacizumab, paclitaxel, and carboplatin or paclitaxel protein-bound and carboplatin, with atezolizumab given before chemotherapy when administered on the same day. Administer the first infusion over 60 minutes; if tolerated, administer subsequent infusions over 30 minutes.
Small cell lung cancer • Extensive-stage
•
840 mg IV q2 weeks until disease progression or unacceptable toxicity
Administered in combination with carboplatin and etoposide, with atezolizumab given before chemotherapy when administered on the same day. Administer the first infusion over 60 minutes; if tolerated, administer subsequent infusions over 30 minutes.
Alternative
•
1,200 mg IV q3 weeks until disease progression or unacceptable toxicity
Administered in combination with carboplatin and etoposide, with atezolizumab given before chemotherapy when administered on the same day. Administer the first infusion over 60 minutes; if tolerated, administer subsequent infusions over 30 minutes.
Alternative
•
1,680 mg IV q4 weeks until disease progression or unacceptable toxicity
Administered in combination with carboplatin and etoposide, with atezolizumab given before chemotherapy when administered on the same day. Administer the first infusion over 60 minutes; if tolerated, administer subsequent infusions over 30 minutes.
Indications for use
Labeled indications
Adults
•
Treatment of alveolar soft part sarcoma (unresectable or metastatic, monotherapy)
•
Treatment of HCC (unresectable or metastatic, no prior systemic therapy)
•
Treatment of melanoma in patients with BRAF V600 mutation (unresectable or metastatic)
•
Treatment of non-small cell lung cancer (metastatic, progressed in patients undergoing or after platinum-based chemotherapy, monotherapy)
•
Treatment of non-small cell lung cancer (stage II-IIIA, PD-L1 expression ≥ 1%, adjuvant setting, monotherapy, following resection and platinum-based chemotherapy)
•
Treatment of non-small cell lung cancer without EGFR mutation, ALK rearrangement (non-squamous, metastatic)
•
Treatment of non-small cell lung cancer without EGFR mutations or ALK genomic aberrations (metastatic, PD-L1 expression ≥ 50% or PD-L1 stained tumor-infiltrating immune cells ≥ 10%, first-line setting, monotherapy)
•
Treatment of non-small cell lung cancer without EGFR mutations or ALK genomic aberrations (non-squamous, metastatic, first-line setting)
•
Treatment of small cell lung cancer (extensive-stage)
Children
•
Treatment of alveolar soft part sarcoma (in patients ≥ 2 years) (unresectable or metastatic, monotherapy)
Safety risks
Contraindications
Hypersensitivity to atezolizumab or its components
Warnings and precautions
GvHD, hepatic veno-occlusive disease
•
Use caution in patients receiving allogeneic HSCT before or after PD-1/PD-L1 blocking antibody treatment, due to potential fatal transplant-related complications. Before treating with PD-1/PD-L1 blocking antibodies, carefully assess benefits versus risks and evaluate patient suitability. Closely monitor patients for transplant-related complications and intervene promptly when identified.
Immune-mediated adverse reactions
•
Maintain a high level of suspicion, as atezolizumab has been associated with an increased risk of severe and fatal immune-mediated adverse reactions, including pneumonitis, colitis, hepatitis, adrenal insufficiency, hypophysitis, thyroid disorders, T1DM, nephritis, dermatitis, and others. Conduct baseline and periodic LFTs, serum creatinine, and thyroid function tests to minimize immune-mediated adverse reactions. Monitor patients closely for symptoms and signs of these reactions. Educate patients to report new or worsening symptoms promptly. Consider pre-emptive corticosteroids for Grade 2 or higher reactions, and promptly initiate workups and management for suspected cases. For Grade 2 adverse reactions, withhold treatment and monitor closely. Consider starting corticosteroids if symptoms persist or worsen. For Grade 3 reactions, withhold treatment and administer corticosteroids at 1-2 mg/kg/day of prednisone (or equivalent). Gradually taper corticosteroids over at least one month, aiming to reach ≤10 mg/day. If there is no improvement within 12 weeks or corticosteroids cannot be tapered to this level, discontinue both corticosteroids and treatment. For Grade 4 reactions, or recurrent Grade 3 reactions requiring systemic immunosuppressive therapy, permanently discontinue treatment. If corticosteroids alone are insufficient to control symptoms, consider additional systemic immunosuppressants.
Infusion-related reactions
•
Maintain a high level of suspicion, as atezolizumab can cause severe or life-threatening infusion-related reactions, including grade 3 adverse reactions. For Grade 1 or 2 infusion-related reactions, consider antipyretic and antihistamine premedication with subsequent doses. Pause or slow the rate of injection for Grade 1 or 2 reactions, and permanently discontinue atezolizumab for Grade 3 or 4 reactions.
Specific populations
Renal impairment
eGFR 0-90 mL/min/1.73 m²
•
Use acceptable. No dose adjustment required.
Renal replacement therapy
Any modality
•
Use acceptable. No dose adjustment required.
Hepatic impairment
Child-Pugh A (mild)
•
Use acceptable. No dose adjustment required.
Child-Pugh B (moderate)
•
Use acceptable. No dose adjustment required.
Child-Pugh C (severe)
•
No guidance available.
Pregnancy and breastfeeding
Pregnancy
All trimesters • Australia Category: D
•
Do not use. Evidence of fetal harm in animals. Verify pregnancy status in females of reproductive potential before initiating treatment. Advise using effective contraception during treatment and for at least 5 months after the last dose.
Breastfeeding
Do not use during breastfeeding.
•
Advise females not to breastfeed for 5 months after the last dose.
Unknown amount excreted in breastmilk.
Unknown drug levels in breastfed infants.
Adverse reactions
Very common > 10%
•
Allergic rhinitis, alopecia, cardiac arrhythmias, drug-induced liver injury, hypertension, hyperthyroidism, hypopituitarism, ↑ urine protein, influenza, infusion-related reactions, neuropathy, photosensitivity of skin, pneumonitis, abdominal pain, anxiety, arthralgia, asthenia, constipation, cough, diarrhea, dizziness, dyspnea, fatigue, fever, generalized pruritus, headache, insomnia, loss of appetite, musculoskeletal pain, myalgia, nausea, skin rash, vomiting, weight loss
Common 1-10%
•
Acute pancreatitis, adrenal insufficiency, carcinomatosis, cardiac arrest, colitis, ↓ LVEF, hepatitis, ↑ blood glucose, nephritis, ↑QT interval, renal failure, metallic taste, nosebleed, syncope, thyroid dysfunction, thyroiditis, urinary tract infections, uveitis, vitiligo
Uncommon < 1%
•
Diabetes mellitus type 1
Rare < 0.1%
•
Hemolytic anemia, hypophysitis
Unknown frequency
•
Aplastic anemia, arthritis, chronic obstructive pulmonary disease, cardiac tamponade, DRESS syndrome, ↓ blood neutrophil count, demyelinating lesions, dermatitis, diabetic ketoacidosis, encephalitis, erythroderma, eyelid swelling, facial edema, gastritis, gastrointestinal hemorrhage, Guillain-Barré syndrome, graft-versus-host disease, hemophagocytic lymphohistiocytosis, hepatic veno-occlusive disease, hypoparathyroidism, interstitial lung disease, ileus, immune thrombocytopenia, ↑ serum ALT, ↑ serum AST, ↑ serum amylase, ↑ serum lipase, infections, iritis, Lambert-Eaton myasthenic syndrome, liver cirrhosis, lymphedema, meningitis, mucositis, myasthenia gravis, myelitis, myocardial infarction, myocarditis, myositis, organ rejection, pulmonary embolism, pericardial effusion, pericarditis, peripheral edema, pneumonia, polymyalgia rheumatica, polymyositis, pulmonary hemorrhage, renal failure, visual disturbances, respiratory distress, rhabdomyolysis, sarcoidosis, sepsis, septic shock, Stevens-Johnson syndrome, stomatitis, stroke, subarachnoid hemorrhage, systemic inflammatory response syndrome, toxic epidermal necrolysis, VT, vasculitis, vogt-Koyanagi-Harada syndrome
Interactions
Drug(s)
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